Leaving GSK Source

You are leaving GSKSource to visit a separate website not associated with GSKSource, a portal for US Healthcare Professionals.There are website links to third-party sites on GSK Source.GSK is not responsible for content on third-party websites.

Leaving GSK Source

You are leaving GSKSource to visit a separate website not associated with GSKSource, a portal for US Healthcare Professionals. There are website links to third-party sites on GSKSource. GSK is not responsible for content on third-party websites.

Estimates of the percentage of people vaccinated are based on interviews conducted beginning September (BRFSS) or October (NIS-FLU) 2016 through June 2017 and reported vaccinations from July 2016 through May 2017. Excludes US territories.

*The data presented above are limited to patients with laboratory-confirmed influenza and those treated with antivirals, therefore these findings are not generalizable to nonhospitalized populations or whether the effects could even be more robust in a population without access to antiviral treatment.

Indication for FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT

FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccines. FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are approved for use in persons aged 6 months and older.

Important Safety Information for FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT

Do not administer FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT should be based on careful consideration of the potential benefits and risks

Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope

If FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons

In clinical trials with FLUARIX QUADRIVALENT in adults, the most common solicited local adverse reaction was pain and the most common systemic adverse reactions were muscle aches, headache, and fatigue. In children 6 through 35 months of age, the most common solicited local adverse reactions were pain and redness and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. In children 3 through 17 years of age, the solicited local adverse reactions were pain, redness, and swelling. In children 3 through 5 years of age, the most common systemic adverse reactions were drowsiness, irritability, and loss of appetite. In children 6 through 17 years of age, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FLUARIX QUADRIVALENT for other potential adverse reactions and events)

In clinical trials with FLULAVAL QUADRIVALENT in adults, the most common solicited local adverse reaction was pain and the most common solicited systemic adverse reactions were muscle aches, headache, fatigue, and arthralgia. In children 6 through 35 months of age, the most common solicited local adverse reaction was pain and the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 3 through 17 years of age, the most common solicited local adverse reaction was pain. In children 3 through 4 years of age, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 5 through 17 years of age, the most common solicited systemic adverse reactions were muscle aches, fatigue, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FLULAVAL QUADRIVALENT for other potential adverse reactions and events)

Vaccination with FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT may not result in protection in all vaccine recipients

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967